Study to Evaluate the Safety and Effect of HIVconsv Vaccines in Combination With Histone Deacetylase Inhibitor Romidepsin on the Viral Rebound Kinetic After Treatment Interruption in Early Treated HIV-1 Infected Individuals
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ClinicalTrials.gov Identifier: NCT02616874 |
Recruitment Status :
Completed
First Posted : November 30, 2015
Last Update Posted : January 17, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV | Drug: MVA.HIVconsv vaccine Drug: Romidepsin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open Label Phase I Trial to Evaluate the Safety and Effect of HIVconsv Vaccines in Combination With Histone Deacetylase Inhibitor Romidepsin on the Viral Rebound Kinetic After Treatment Interruption in Early Treated HIV-1 Infected Individuals (BCN02-Romi) |
Study Start Date : | February 2016 |
Actual Primary Completion Date : | September 2016 |
Actual Study Completion Date : | October 30, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: MVA.HIVconsv plus romidepsin
MVA.HIVconsv plus romidepsin
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Drug: MVA.HIVconsv vaccine
Dose: 2x10e8 pfu, Interval: weeks 0 and 9. Drug: Romidepsin Dose: 5mg/m2 over 4hours, Interval: weeks 3, 4 and 5 |
- Number of participants with grade >=3 adverse events assessed by Division of AIDS (DAIDS) grading table [ Time Frame: Through study completion, maximum 75 weeks ]Grade >=3 adverse events
- Number of participants with serious adverse events [ Time Frame: Through study completion, maximum 75 weeks ]Serious adverse events
- Viral reservoir measured by total HIV-1 DNA copies per 10e6 CD4+ T cells [ Time Frame: From baseline to visit week 6 (romidepsin 3 + 1 week) ]Total HIV-1 DNA copies per 10e6 CD4+ T cells
- Romidepsin Cmax [ Time Frame: week 3 ]RMD plasma concentrations will be measured by Liquid chromatography-mass spectrometry (LC-MS/MS)
- Romidepsin Cmax [ Time Frame: week 4 ]RMD plasma concentrations will be measured by LC-MS/MS
- Romidepsin Cmax [ Time Frame: week 5 ]RMD plasma concentrations will be measured by LC-MS/MS
- Romidepsin Cmin [ Time Frame: week 3 ]RMD plasma concentrations will be measured by LC-MS/MS
- Romidepsin Cmin [ Time Frame: week 4 ]RMD plasma concentrations will be measured by LC-MS/MS
- Romidepsin Cmin [ Time Frame: week 5 ]RMD plasma concentrations will be measured by LC-MS/MS
- Romidepsin area under curve (AUC) [ Time Frame: week 3 ]RMD plasma concentrations will be measured by LC-MS/MS
- Romidepsin AUC [ Time Frame: week 4 ]RMD plasma concentrations will be measured by LC-MS/MS
- Romidepsin AUC [ Time Frame: week 5 ]RMD plasma concentrations will be measured by LC-MS/MS
- HIV-1 expression in resting CD4+ T-cells measured by CA-RNA and single-copy assay (SCA) [ Time Frame: week 6 ]
- Levels of Histone H3 acetylation in lymphocytes [ Time Frame: week 6 ]
- CTL toxicity assessment based on viability, activation or exhaustion (most relevant marker according to previous studies) [ Time Frame: week 6 ]
- HIVconsv-specific T cell responses will be measured by IFNg ELISPOT using peptide pools covering different HIV proteins and HIVcons sequences. [ Time Frame: week 6 ]
- Viral suppressive capacity of CD8+ T cells in vitro, using a flow cytometric assay [ Time Frame: Baseline ]
- Viral suppressive capacity of CD8+ T cells in vitro, using a flow cytometric assay [ Time Frame: Week 17 ]
- Proportion of individuals who initiate a MAP following the futility analysis [ Time Frame: Week 17 ]
- Proportion of individuals who maintain sustained plasma viral load (pVL) <2,000 copies/ml [ Time Frame: Week 29 ]
- Proportion of individuals in whom cART is reinitiated due to viral rebound [ Time Frame: Up to 51 weeks ]
- Emergence of viral resistance during MAP phase [ Time Frame: Up to 51 weeks ]Description of viral resistance emerged, genotype.
- Proportion of patients with viral suppression 6 months after treatment resumption. [ Time Frame: 24 weeks after treatment resumption (up to 75 weeks). ]

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject included in ChAd-MVA.HIVconsv_BCN01 study with complete follow-up and included in BCN01-RO extension study.
- Optimal virological suppression for at least 3 years.cop/ml).
- Being on a non-boosted integrase-inhibitor based regimen (raltegravir or dolutegravir) for at least 4 weeks at screening visit.
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Haematological and biochemical laboratory parameters as follows:
- Haemoglobin > 10g/dl
- Platelets > 100.000/dl
- Alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN)
- Creatinine ≤ 1.3 x ULN
- CD4 T cell count ≥500 cells/mm3
Exclusion Criteria:
- Positive pregnancy test.
- Presence of resistance drug mutations in the screening genotype
- History of autoimmune disease other than HIV-related auto-immune disease.
- Treatment for cancer or lymphoproliferative disease within 1 year of study entry
- Any other prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study
- Current or recent use (within last 3 months) of interferon or systemic corticosteroids or other immunosuppressive agents

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616874
Spain | |
Germans Trias i Pujol Hospital | |
Badalona, Barcelona, Spain, 08916 | |
Clinic Hospital | |
Barcelona, Spain, 08036 |
Responsible Party: | IrsiCaixa |
ClinicalTrials.gov Identifier: | NCT02616874 |
Other Study ID Numbers: |
BCN02-Romi |
First Posted: | November 30, 2015 Key Record Dates |
Last Update Posted: | January 17, 2018 |
Last Verified: | January 2018 |
HIV infection Early treatment Romidepsin HDACi |
Therapeutic Vaccines HIVconsv HIV reservoir Population PK/PD analysis |
Romidepsin Antibiotics, Antineoplastic Antineoplastic Agents |